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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K242503

510(k) cleared

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

Eurosets S.R.L · Nov 24, 2025 · K242503

FDA cleared the Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) from Eurosets S.R.L on Nov 24, 2025 under K242503, a traditional 510(k). The device falls under product code DTZ, Oxygenator, Cardiopulmonary Bypass, regulated at 21 CFR 870.4350 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 22, 2024. The decision came 459 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Eurosets S.R.L has one other decision in the tracker over the last 12 months: K250821 (Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)).

Questions & Answers

What did FDA clear under K242503?

K242503 is the FDA 510(k) for Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232), submitted by Eurosets S.R.L. FDA's decision date was Nov 24, 2025, under product code DTZ (Oxygenator, Cardiopulmonary Bypass).

Who makes the Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?

Eurosets S.R.L, based in Medolla, is the applicant of record for K242503.

How long did the K242503 review take?

FDA received the submission on Aug 22, 2024 and issued its decision on Nov 24, 2025, 459 days later.

← All decisions in November 2025

Sources